Attention Deficit Hyperactivity DisorderNCT04282460
Ba Duan Jin in Treatment of Attention Deficit Hyperactivity Disorder
A study testing Baduanjin practice and Regular physical exercise in people with Attention Deficit Hyperactivity Disorder, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
This study is designed to test if Baduanjin training can reduce the hyperactive-impulsive symptoms of children with Attention deficit hyperactivity disorder (ADHD) compared to routine excise. Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Baduanjin practice and Regular physical exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 24 Oct 2020to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed with ADHD, Combined Presentation or Predominantly Hyperactive-Impulsive Presentation
- Doctor rated SNAP-IV Hyperactivity/Impulsivity score≥12
- Full-Scale Intelligence Quotient>=80 (Wechsler intelligence scale for children-IV)
- Resident in Shanghai，Zhejiang province and Jiangsu province, parents and children agree to participate in the intervention
Who cannot join
- Using psychiatric medication other than methylphenidate
- Attending any other type of regular physical exercises except the gym class in school during the intervention period
- Accepting any type of psychological treatment during the intervention
- Comorbid with epileptic disorder or other existing physical disorder, Tourette syndrome, Autism Spectrum Disorder, learning disorder, mood disorder, psychiatric disorder, or under suicidal risk
- Attending any other clinical research at the same time
Trial locations and contacts
1 site in 1 country.
China1 site
Children's hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
Official title: A Randomized Clinical Trial of Ba Duan Jin in Treatment of Attention Deficit Hyperactivity Disorder With Hyperactive-Impulsive Symptom
This study is designed to test if Baduanjin training can reduce the hyperactive-impulsive symptoms of children with Attention deficit hyperactivity disorder (ADHD) compared to routine excise. Investigators will also evaluate if the Baduanjin training will positively affect Chinese Traditional Medicine (TCM) symptoms compared to controls and if these impacts are related to the change of the executive function.
Read the detailed description
ADHD is a common neurodevelopmental disorder characterized by a persistent pattern of inattention and/or hyperactivity and impulsivity, resulting in functional impairment in multiple settings. The prevalence in China is estimated to be 6.26%. From the point of Chinese Traditional Medicine (TCM), ADHD can be divided into 4 categories according to the symptom differentiation in TCM.
Aerobic exercise is known to improve executive function (EF) performance, which is known as the core deficit of ADHD, therefore reduce ADHD symptoms. Aerobic exercise with the component of self-control and development of character is reported to improve EF.
Baduanjin is one of the aerobic exercises that has been handed down since the northern song dynasty, serving as Chinese physical and breathing exercises. The eight movements of Baduanjin are required to be gentle, slow, elastic and appropriate which not only require the practitioner to control physical activity but also require a combination of cognitive activities. Researchers found that Baduanjin has a positive protective effect on cognitive function such as selective attention in patients with mild cognitive impairment adults.
Therefore, investigators designed the Baduanjin training system. This is a combination of a physical and cognitive training program and a video game with a motivation system, interesting and engaging for children with ADHD to practice on.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Baduanjin practice, Regular physical exercise
- Keywords
- Chinese traditional medicine
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baduanjin practiceBehavioural
Use the Baduanjin training system to practice the whole set of Baduanjin at least once a day and at least 5 days each week for 3 months.
Regular physical exerciseBehavioural
Take physical exercise for at least half an hour every day in addition to regular physical activities at school.
| Study group | Role | What they receive |
|---|---|---|
| Baduanjin practice | Experimental | Baduanjin practice group will be asked to use the Baduanjin training system to practice the whole set of Baduanjin at least once a day and at least 5 days each week for 3 months. Receives: Behavioral: Baduanjin practice |
| Regular physical exercise | Active comparator | The regular physical exercise group will be asked to take physical exercise for at least half an hour every day in addition to regular physical activities at school. Receives: Behavioral: Regular physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyperactivity/Impulsivity score change in SNAP-IV scale
The Swanson, Nolan, and Pelham Questionnaire (SNAP-IV) Rating Scale is a revised version of the Swanson, Nolan and Pelham (SNAP) Questionnaire that utilizes the DSM-IV criteria for ADHD and oppositional defiant disorder, rated by caregiver or professionals. It comprises three subscales: Inattention, Hyperactivity/Impulsivity, and Oppositional Defiant Disorder. The score of each item is rated with a 4-point Likert scale (0 = not at all, 3 = very much). We choose the 9-item-Hyperactivity/Impulsivity subscale for the evaluation of change in ADHD Hyperactivity/Impulsivity symptom in children. The score of Hyperactivity/Impulsivity subscale is calculated by adding the 9 items, the score will range from 0 to 27. The change of score is calculated by Hyperactivity/Impulsivity score at 3 months enrollment (both Baduanjin practice group and Regular physical exercise group went through 3 months of intervention at this point) minus Hyperactivity/Impulsivity score at baseline (enrollment).
Measured: Baseline, 3 months after enrollment
Secondary outcomes (1)
Change of Scoring evaluation of the TCM symptoms
The TCM symptom scale was developed from the guideline system for traditional Chinese medicine new drug clinical research to evaluate the severity of TCM symptoms of children. This scale include 23 items, each presents one common TCM symptom. Each symptom is rated 1-4 points according to its severity. The total score is calculated by adding the scores of all 23 items. The change of score is calculated by TCM symptoms score after 3 months of enrollment (both Baduanjin practice group and Regular physical exercise group went through 3 months of intervention at this point) minus TCM symptoms score at baseline (enrollment).
Measured: Baseline, 3 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start24 Oct 2020
- Primary completion30 Nov 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The present study will be carried out using a parallel randomized study design. Each participant will be randomly assigned either to the Baduanjin intervention or to the regular physical exercise control group.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Municipal Science and Technology Commission
- Responsible party
- Sponsor
- Investigators
- Daqian Zhu, PhD, Study chair, Department of Psychological Medicine, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282460
- Sponsor's protocol ID
- 19401931200
- Status last verified
- Jan 2023
- First submitted
- 21 Feb 2020
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Davis CL, Tomporowski PD, McDowell JE, Austin BP, Miller PH, Yanasak NE, Allison JD, Naglieri JA. Exercise improves executive function and achievement and alters brain activation in overweight children: a randomized, controlled trial. Health Psychol. 2011 Jan;30(1):91-8. doi: 10.1037/a0021766.
PubMed 21299297Drollette ES, Scudder MR, Raine LB, Moore RD, Saliba BJ, Pontifex MB, Hillman CH. Acute exercise facilitates brain function and cognition in children who need it most: an ERP study of individual differences in inhibitory control capacity. Dev Cogn Neurosci. 2014 Jan;7:53-64. doi: 10.1016/j.dcn.2013.11.001. Epub 2013 Nov 16.
PubMed 24309300Pontifex MB, Saliba BJ, Raine LB, Picchietti DL, Hillman CH. Exercise improves behavioral, neurocognitive, and scholastic performance in children with attention-deficit/hyperactivity disorder. J Pediatr. 2013 Mar;162(3):543-51. doi: 10.1016/j.jpeds.2012.08.036. Epub 2012 Oct 17.
PubMed 23084704Verburgh L, Konigs M, Scherder EJ, Oosterlaan J. Physical exercise and executive functions in preadolescent children, adolescents and young adults: a meta-analysis. Br J Sports Med. 2014 Jun;48(12):973-9. doi: 10.1136/bjsports-2012-091441. Epub 2013 Mar 6.
PubMed 23467962
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Ba Duan Jin in Treatment of Attention Deficit Hyperactivity Disorder With Hyperactive-Impulsive Symptom
- ClinicalTrials.gov ID
- NCT04282460
- Acronym / sponsor ID
- 19401931200
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Chinese traditional medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Shanghai Municipal Science and Technology Commission
- Study start
- 24 Oct 2020 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 24 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to test if Baduanjin training can reduce the hyperactive-impulsive symptoms of children with Attention deficit hyperactivity disorder (ADHD) compared to routine excise. Investigators will also evaluate if the Baduanjin training will positively affect Chinese Traditional Medicine (TCM) symptoms compared to controls and if these impacts are related to the change of the executive function.
Detailed description
ADHD is a common neurodevelopmental disorder characterized by a persistent pattern of inattention and/or hyperactivity and impulsivity, resulting in functional impairment in multiple settings. The prevalence in China is estimated to be 6.26%. From the point of Chinese Traditional Medicine (TCM), ADHD can be divided into 4 categories according to the symptom differentiation in TCM.
Aerobic exercise is known to improve executive function (EF) performance, which is known as the core deficit of ADHD, therefore reduce ADHD symptoms. Aerobic exercise with the component of self-control and development of character is reported to improve EF.
Baduanjin is one of the aerobic exercises that has been handed down since the northern song dynasty, serving as Chinese physical and breathing exercises. The eight movements of Baduanjin are required to be gentle, slow, elastic and appropriate which not only require the practitioner to control physical activity but also require a combination of cognitive activities. Researchers found that Baduanjin has a positive protective effect on cognitive function such as selective attention in patients with mild cognitive impairment adults.
Therefore, investigators designed the Baduanjin training system. This is a combination of a physical and cognitive training program and a video game with a motivation system, interesting and engaging for children with ADHD to practice on.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The present study will be carried out using a parallel randomized study design. Each participant will be randomly assigned either to the Baduanjin intervention or to the regular physical exercise control group.
| Arm | Type | Receives |
|---|---|---|
| Baduanjin practice | Experimental | Behavioral: Baduanjin practiceBaduanjin practice group will be asked to use the Baduanjin training system to practice the whole set of Baduanjin at least once a day and at least 5 days each week for 3 months. |
| Regular physical exercise | Active comparator | Behavioral: Regular physical exerciseThe regular physical exercise group will be asked to take physical exercise for at least half an hour every day in addition to regular physical activities at school. |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Diagnosed with ADHD, Combined Presentation or Predominantly Hyperactive-Impulsive Presentation
- Doctor rated SNAP-IV Hyperactivity/Impulsivity score≥12
- Full-Scale Intelligence Quotient>=80 (Wechsler intelligence scale for children-IV)
- Resident in Shanghai，Zhejiang province and Jiangsu province, parents and children agree to participate in the intervention
Key exclusion criteria (5 listed)
- Using psychiatric medication other than methylphenidate
- Attending any other type of regular physical exercises except the gym class in school during the intervention period
- Accepting any type of psychological treatment during the intervention
- Comorbid with epileptic disorder or other existing physical disorder, Tourette syndrome, Autism Spectrum Disorder, learning disorder, mood disorder, psychiatric disorder, or under suicidal risk
- Attending any other clinical research at the same time
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baduanjin practiceUse the Baduanjin training system to practice the whole set of Baduanjin at least once a day and at least 5 days each week for 3 months. | Behavioural | Baduanjin practice |
| Regular physical exerciseTake physical exercise for at least half an hour every day in addition to regular physical activities at school. | Behavioural | Regular physical exercise |
Primary outcome
Hyperactivity/Impulsivity score change in SNAP-IV scale
Time frame: Baseline, 3 months after enrollment
The Swanson, Nolan, and Pelham Questionnaire (SNAP-IV) Rating Scale is a revised version of the Swanson, Nolan and Pelham (SNAP) Questionnaire that utilizes the DSM-IV criteria for ADHD and oppositional defiant disorder, rated by caregiver or professionals. It comprises three subscales: Inattention, Hyperactivity/Impulsivity, and Oppositional Defiant Disorder. The score of each item is rated with a 4-point Likert scale (0 = not at all, 3 = very much). We choose the 9-item-Hyperactivity/Impulsivity subscale for the evaluation of change in ADHD Hyperactivity/Impulsivity symptom in children. The score of Hyperactivity/Impulsivity subscale is calculated by adding the 9 items, the score will range from 0 to 27. The change of score is calculated by Hyperactivity/Impulsivity score at 3 months enrollment (both Baduanjin practice group and Regular physical exercise group went through 3 months of intervention at this point) minus Hyperactivity/Impulsivity score at baseline (enrollment).
1 secondary outcome
Change of Scoring evaluation of the TCM symptoms
Time frame: Baseline, 3 months after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Background: PubMed 21299297Davis CL, Tomporowski PD, McDowell JE, Austin BP, Miller PH, Yanasak NE, Allison JD, Naglieri JA. Exercise improves executive function and achievement and alters brain activation in overweight children: a randomized, controlled trial. Health Psychol. 2011 Jan;30(1):91-8. doi: 10.1037/a0021766.
- Background: PubMed 24309300Drollette ES, Scudder MR, Raine LB, Moore RD, Saliba BJ, Pontifex MB, Hillman CH. Acute exercise facilitates brain function and cognition in children who need it most: an ERP study of individual differences in inhibitory control capacity. Dev Cogn Neurosci. 2014 Jan;7:53-64. doi: 10.1016/j.dcn.2013.11.001. Epub 2013 Nov 16.
- Background: PubMed 23084704Pontifex MB, Saliba BJ, Raine LB, Picchietti DL, Hillman CH. Exercise improves behavioral, neurocognitive, and scholastic performance in children with attention-deficit/hyperactivity disorder. J Pediatr. 2013 Mar;162(3):543-51. doi: 10.1016/j.jpeds.2012.08.036. Epub 2012 Oct 17.
- Background: PubMed 23467962Verburgh L, Konigs M, Scherder EJ, Oosterlaan J. Physical exercise and executive functions in preadolescent children, adolescents and young adults: a meta-analysis. Br J Sports Med. 2014 Jun;48(12):973-9. doi: 10.1136/bjsports-2012-091441. Epub 2013 Mar 6.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daqian Zhu, PhD study chair
Department of Psychological Medicine, Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baduanjin practice and Regular physical exercise in people with Attention Deficit Hyperactivity Disorder, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hyperactivity/Impulsivity score change in SNAP-IV scale (time frame: Baseline, 3 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04282460, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.